Product Selection And Development Strategy
Why It Matters
A strong product selection and development strategy ensures that your product is not only technically feasible, but also meets unmet market needs, regulatory requirements, and commercial viability.
It helps you avoid costly missteps, delays, or developing products that don’t align with your capabilities, brand or market trends.
Our Approach
We structure our services in a step-by-step, consultative model, aligning scientific, regulatory, operational & commercial perspectives.
We follow a structured, step-by-step model that integrates scientific, regulatory, operational, and commercial perspectives.
Market & Opportunity Analysis
- Identify high-potential therapeutic areas and regulatory pathways.
- Assess competition, unmet needs, and market access landscape.
Technical & Feasibility Assessment
- Evaluate APIs, excipients, technologies, and formulation aspects.
- Assess infrastructure, resources, and regulatory readiness.
Regulatory & QbD Strategy
- Define Target Product Profiles (TPPs) and risk management plans.
- Map optimal regulatory pathways (generic, biosimilar, expedited).
Business Case & Financial Planning
- Estimate development cost, timelines, and ROI.
- Build revenue projections and prioritize product ideas.
Development Roadmap & Execution
- Define milestones, studies, and scale-up plans.
- Support formulation, testing, supply chain, and manufacturing setup.
Positioning & Lifecycle Planning
- Establish product differentiators and market entry timing.
- Plan lifecycle extensions and access strategies.
Continuous Monitoring & Optimization
- Conduct post-launch performance tracking and risk monitoring.
- Update strategy based on market and regulatory changes.
Our Clients
